Additive container for medicants or the like



1964 R, w. BARTON ETAL 3,143,251

ADDITIVE CONTAINER FOR MEDICANTS OR THE LIKE Filed June 9. 1961 llV VE/V TORS United States Patent 3,143,251 ADEHTIVE CSNTAINER FER MEDICANTS 0R THE LIKE Raymond W. Barton and Joe T. Herrera, Evansviiie, 1nd,,

essignors, by mesne assignments, to Don Baxter, Inc,

Glendale, Calif., a corporation of Nevada Filed lune 9, 1961, Ser. No. 116,943 claims. or. 222-209 This invention relates to an improved container and closure for the addition of medication or other materials to bulk parenteral solutions.

Farenteral solutions are frequently injected into the body when it is desired to get a nutrient or medicament into the patients body without delay, or to feed a patient who is not able to receive food by mouth. Many ingredients which would desirably be included in such solutions are unstable in solution. They are, therefore, added to the solution just before administration. US. Patents 3,633,203 and 3,059,643 granted to Raymond W. Barton disclose a container and closure for facilitating addition of such ingredients to a parenteral solution container. Another US. Patent 3,066,833, discloses an improved additive container. This invention is concerned with improvements over the apparatus disclosed in these previous patents.

In the additive containers disclosed in the previous applications, a rubber closure serves as a pumping device to aseptically transfer solution from a parenteral solution container into the additive container, and after the additive is dissolved, to transfer the dissolved additive back to the parenteral solution container. A rigid connector extending from the rubber closure serves as a means for connecting the additive container to the solution container. The pumping operation is performed with the additive container below the solution container by first pushing the additive container toward the parenteral solution container to collapse the closure and expel air from the additive container, then pulling the additive container away from the parenteral solution container to expand the closure and draw solution into the additive container. When the additive container is pulled away from the parenteral solution container, the rigid connector may be pulled loose from one of the containers. Moreover, it is awkward to hold both containers while pulling the additive container away from the solution container.

In some procedures, it is desirale to add a definite amount of solution from an additive container to a parenteral solution container. This desired amount may be less than the entire contents of the additive container. In the additive containers disclosed in the previous applications, the amount of solution expelled with each pumping stroke of the additive container has been difiicult to control because the closure is not collapsed in a consistent manner each time. Also, precautions have had to be taken to assure that the rather drastic deformation of the closure does not detach it from the additive container.

In other procedures, it is desirable to transfer the solution to and from the additive container as rapidly as possible.

It is, therefore, an object of this invention to provide an additive container having an improved pumping closure for rapidly transferring liquids to and from the container.

Another object of the invention is to provide an additive container having a pumping closure which will expand itself when released from a distorting force.

Another object of the invention is to provide a pumping closure having a more uniform pumping volume.

A further object of the invention is to provide an additive container and pumping closure in which deformation ice of the closure has a reduced tendency to separate the closure from the additive container.

A still further object of the invention is to provide a pumping closure capable of rapidly transferring solution to and from an additive container.

Further features and advantages of the invention will be apparent from the following specification and from the drawings, in which:

FIGURE 1 is an elevational view, partially cut away, of a container embodying the invention;

FIGURE 2 is an enlarged fragmentary sectional view, with portions shown in elevation, of the invention with the protector removed and the connector inserted into the stopper of a parenteral solution bottle;

FIGURE 3 is a view similar to FIGURE 2 with the pumping portion of the closure deformed; and

FIGURE 4 is a view similar to FIGURE 3 with the pumping portion of the closure further deformed.

As shown in the drawings, the additive container includes a bottle 10. A deformable pumping closure 11 is attached to bottle 10 by a retaining ring 12, preferably made of metal. A connecting device 13 extends from the upper end of closure 11 and is adapted to be inserted into a stopper 37 of a bulk parenteral solution container 38. Prior to use, a protector 14 covers the end of connector 13.

Bottle 10 has a neck 15, the inner surface of which defines an opening or mouth 16. An annular flange or rim 18 projects outwardly from neck 15.

Closure 11 has a skirt 20 which fits into the bottle mouth 16 and which terminates in an outwardly tapering, annular surface 21. A portion of closure 11 extends upward from skirt 20 above the top of bottle 10 and has an outwardly projecting flange 19 which seats against the top surface of the bottle and which is held in place by retaining ring 12. A cylindrical section 22 of closure 11 extends above flange 19 and has thick, substantially vertical walls, so as to be relatively stiff. A head 23 projects horizontally from the outer surface at the top of cylindrical section 22.

Above cylindrical section 22, closure 11 has a domeshaped pumping portion 25, the inner surface 26 of which has a frusto-conical shape. The outer surface 27 of pumping portion 25 has the shape of a spherical zone and curves toward the top of inner surface 26 to provide pumping portion 25 with a decreasing thickness towards the thin upper section 28. This configuration gives an annular zone of inflection at upper section 28. The annular zone of initial inflection occurs at the juncture between tubular sleeve 29 and dome-shaped pumping portion 25. Pumping portion 25 is made of natural rubber or other highly resilient, flexible material. The walls of pumping portion 25 are thinner and considerably more flexible than the walls of cylindrical section 22. A tubular sleeve 29 projects from the upper section of pumping portion 25 and is adapted to receive a tubular section of connector 13 which preferably seats against an annular flange 3%.

Connecting member 13 has a manually engageable flange 33 and a tubular section 32, the latter telescoping into the closure sleeve 29. Above flange 33, connector 13 has a protector hub 36 adapted to receive protector 14. Above hub 36, connector 13 has an insertion tip 34, having a point 35. Point 35 and insertion tip 34 are adapted to pierce the diaphragm closing the outlet passage of stopper 37 of parenteral solution bottble 38 and to fit tightly within said passage.

Retaining ring 12 has a cylindrical section 40 and a horizontal top flange 41, the latter fitting around cylindrical section 22 and having an inner diameter greater than the outer diameter of bead 23. In this way, ring 12 can be preassemhled onto closure 11 and will be retained thereon by head 23. The lower end of retaining ring 12 is rolled or formed around the underside of bottle rim 18 so as to form the bottom flange 42, permanently holding ring 12 on bottle and urging the top ring flange 41 down against the stopper flange 19.

In use, protector 14 is removed and insertion tip 34 pushed through the diaphragm of stopper 37 into parenteral solution container 38. Closure 11 is not collapsed by vacuum, customarily present in solution container 38, because of the stiffness and resilience of dome-shaped portion 25.

The two containers are then held with the parenteral solution container 38 inverted and above the additive container. The additive container is then pushed upward, deforming closure 11 and expelling air from additive container 10 into container 38. Closure 11 deforms by bending of the pumping portion 25 downwardly around the lower end of said portion. This bending is initiated in the thin upper section 28 and progresses down through pumping portion 25 until the pump bottoms out in the position shown in FIGURE 3.

Further upward movement of additive container 10 deforms cylindrical closure section 22 until the pump again bottoms out in the position shown in FIGURE 4. This requires noticeably more force and causes bead 23 to roll inwardly, thus indicating to the operator that this section is being deformed. Cylindrical section 22 facilitates bending of pumping portion 25 by serving as a base around WhiCh portion 25 bends and by insulating flange 19 and skirt from deformation. Such deformation would tend to pull closure 11 loose from bottle 10 or to pull skirt 20 away from b'ottle mouth 16, forming a space in which liquid could be trapped.

The upward force on the additive container is then released and the resilience of the bent pumping portion causes closure 11 to snap back to its original position (FIGURE 2). This draws solution from container 38 into additive container 10. The pumping process is then repeated until the desired amount of solution has been pumped from container 38 into container 10.

After the additive ingredients in container 10 are dissolved, the containers are inverted so that additive container 10 is upside down and above container 38. Additive container 10 is then pushed down, deforming closure 11 and expelling solution and dissolved additive ingredients from container 10 into container 38. Again, closure 11 snaps back to its original shape (FIGURE 2) when released, drawing air from container 38 into additive container 10. Closure 11 is thus ready for additional pumping or deforming strokes. Since pumping portion 25 bottoms out sharply at the position shown in FIGURE 3, a consistent amount of the additive solution is transferred to container 38 with each stroke. If desired, the solution can be transferred more rapidly by applying additional downward force to container 10, deforming the cylindrical closure section 22 and transferring a second increment of additive solution into container 38. When all solution has been transferred to container 38, additive container 10 is removed, an administration set is attached to container 38 and the solution is administered to the patient.

While we have shown and described certain specific embodiments of our invention for the purpose of illustration, it is understood that many changes and modifications may be made without departing from the scope and spirit of our invention.

We claim:

1. An axially operable, two-stage dispensing-pump-andclosure member, in combination with a container neck and tubular connector having one end portion for insertion in a sealing portion 'of a parenteral solution bottle or the like, said dispensing-pump-and-closure member comprising a resilient tubular member including a lower sealing flange sealingly engageable on the upper end of said container neck, said tubular member including an annular, axially-and-inwardly deformable first pump section extending vertically from the upper surface of said flange and defining a cylindrical first pump chamber therewithin, said tubular member including an axiallyand-inwardly deformable second pump section extending vertically and radially inwardly from the upper end of said first pump section and including a dome-shaped wall portion defining a second pump chamber and being progressively reduced in cross-section from the upper end of said first pump section and progressively increasing in flexibility therefrom, said dome-shaped wall portion forming a substantially annular zone of inflection at the upper end of said first pump section, and a tubular sleeve relatively more rigid than said dome-shaped wall portion and extending axially and vertically from the upper end thereof, said sleeve including a lower portion relatively thicker than the upper end of said dome-shaped wall portion and forming an annular zone of initial inflection substantially at the juncture between said sleeve and said dome-shaped wall portion when said sleeve is displaced axially into said second pump chamber, said connector having another end received in said tubular sleeve and further rigidifying the same to facilitate inward axial displacement through said pump chambers and progressive axial deformation of said pump sections for incrementally pumping fluid.

2. The structure of claim 1 in which said relatively thicker lower portion of said sleeve comprises an inwardly extending annular portion above the upper end of said dome-shaped wall portion.

3. The structure of claim 1 in which said tubular member includes a skirt depending below said flange and sealingly engaged within said container neck.

4. The structure of claim 1 including an annular retaining ring engaged over said flange and around said container neck.

5. The structure of claim 1 in which said first pump section includes an integral, outwardly extending head portion disposed substantially at the juncture between said pump sections for insuring independent axial deformation between said pump sections.

References Cited in the file of this patent UNITED STATES PATENTS 887,919 Carpenter May 19, 1908 929,360 Wright July 27, 1909 2,494,518 Oakes Jan. 10, 1950 2,546,681 Searer Mar. 27, 1951 2,684,674 Archer July 27, 1954 2,734,665 Flamm Feb. 14, 1956 

1. AN AXIALLY OPERABLE, TWO-STAGE DISPENSING-PUMP-ANDCLOSURE MEMBER, IN COMBINATION WITH A CONTAINER NECK AND TUBULAR CONNECTOR HAVING ONE END PORTION FOR INSERTION IN A SEALING PORTION OF A PARENTERAL SOLUTION BOTTLE OR THE LIKE, SAID DISPENSING-PUMP-AND-CLOSURE MEMBER COMPRISING A RESILIENT TUBULAR MEMBER INCLUDING A LOWER SEALING FLANGE SEALINGLY ENGAGEABLE ON THE UPPER END OF SAID CONTAINER NECK, SAID TUBULAR MEMBER INCLUDING AN ANNULAR, AXIALLY-AND-INWARDLY DEFORMABLE FIRST PUMP SECTION EXTENDING VERTICALLY FROM THE UPPER SURFACE OF SAID FLANGE AND DEFINING A CYLINDRICAL FIRST PUMP CHAMBER THEREWITHIN, SAID TUBULAR MEMBER INCLUDING AN AXIALLYAND-INWARDLY DEFORMABLE SECOND PUMP SECTION EXTENDING VERTICALLY AND RADIALLY INWARDLY FROM THE UPPER END OF SAID FIRST PUMP SECTION AND INCLUDING A DOME-SHAPED WALL PORTION DEFINING A SECOND PUMP CHAMBER AND BEING PROGRESSIVELY REDUCED IN CROSS-SECTION FROM THE UPPER END OF SAID FIRST PUMP SECTION AND PROGRESSIVELY INCREASING IN FLEXIBILITY THEREFROM, SAID DOME-SHAPED WALL PORTION FORMING A SUBSTANTIALLY ANNULAR ZONE OF INFLECTION AT THE UPPER END OF SAID FIRST PUMP SECTION, AND A TUBULAR SLEEVE RELATIVELY MORE RIGID THAN SAID DOME-SHAPED WALL PORTION AND EXTENDING AXIALLY AND VERTICALLY FROM THE UPPER END THEREOF, SAID SLEEVE INCLUDING A LOWER PORTION RELATIVELY THICKER THAN THE UPPER END OF SAID DOME-SHAPED WALL PORTION AND FORMING AN ANNULAR ZONE OF INITIAL INFLECTION SUBSTANTIALLY AT THE JUNCTURE BETWEEN SAID SLEEVE AND SAID DOME-SHAPED WALL PORTION WHEN SAID SLEEVE IS DISPLACED AXIALLY INTO SAID SECOND PUMP CHAMBER, SAID CONNECTOR HAVING ANOTHER END RECEIVED IN SAID TUBULAR SLEEVE AND FURTHER RIGIDIFYING THE SAME TO FACILITATE INWARD AXIAL DISPLACEMENT THROUGH SAID PUMP CHAMBERS AND PROGRESSIVE AXIAL DEFORMATION OF SAID PUMP SECTIONS FOR INCREMENTALLY PUMPING FLUID. 